Reconsenting Participants

Learn how to reconsent a participant if they need to re-sign a consent form.

Note Veeva eConsent may be provided by your sponsor for use on a Connected Study or enabled for your SiteVault account as a paid add-on to use across all studies. Contact the Site Success Team to learn more.

Reconsenting a Participant

If you want to reconsent a participant, you can send either the same version or a new version of the blank ICF that the participant and signatories signed before. Additionally, you don’t need to send an updated version if you sent the previous Approved for Use version to the participant and the participant or their signatories haven’t signed yet. The MyVeeva user always sees the latest approved version in MyVeeva for Patients up until the point when they sign.

To reconsent a participant, complete the following steps:

  1. Ensure that the new version of the blank ICF is in an Approved for Use state and that the prerequisites in the Prerequisites section are met.
  2. Optional: If you need to update an existing approved ICF, select the ICF beneath the Document Name column on the Blank Forms tab. The document viewer opens. From the All Actions menu, select Create Draft. In the Create Draft pop-up, select Copying from current version and then select Create. Follow the workflows in the Viewing, Editing, Previewing, and Approving Connected eConsent Forms section to edit, check in, and approve the ICF when it’s ready.
  3. Repeat the steps in the Consenting Participants section and send the latest approved version of the ICF or ICFs.

Note When you send a new version of an ICF to a patient, the eConsent form is displayed on their list of documents as a new version. When they sign and submit the new version, it will be added to SiteVault and the approver will be assigned a task to countersign the new version.

Countersigning eConsent Forms
Viewing and Reporting on eConsent Form Responses
Knowledge Base
System Information
Site Tools